Arena Seeks Approval in Switzerland - Analyst Blog

By: Zacks.com

Posted: 7/13/2012 12:46:00 PM

Referenced Stocks: ARNA;MAA;OREX;VVUS

Close on the heels of the US approval of its weight loss drug
lorcaserin HCl (US trade name: Belviq),
Arena Pharmaceuticals, Inc.
(
ARNA
) filed a Marketing Authorization Application (MAA) seeking to get
the drug approved in Switzerland.

Arena Pharma is looking to get lorcaserin approved as an adjunct
to diet and exercise for weight control in obese (Body Mass Index,
or BMI, >30) or overweight (BMI >27) patients suffering from
at least one weight-related co-morbid condition. Arena Pharma's
marketing application is expected to be accepted by the Swiss
agency for Therapeutic Products (Swissmedic) later this month.

Arena Pharma is seeking approval for lorcaserin in Switzerland
on the basis of data from three double-blind, randomized,
placebo-controlled studies. Results from the studies revealed that
treatment with lorcaserin in combination with diet and exercise was
more effective than only diet and exercise in helping patients to
lose 5% or more of their weight after one year and managing the
weight loss for up to two years.

We note that apart from being approved in the US, lorcaserin is
under review in the EU. Approval in the EU and Switzerland would
boost the sales potential of the drug.

Our Recommendation

Currently, we have a long-term Neutral recommendation on Arena
Pharma. The stock carries a Zacks #2 Rank (Buy rating) in the short
run. We believe that the US approval of lorcaserin is responsible
for the positive short-term stance. We are also positive on the
company's efforts to get the drug approved in additional markets.
Other companies that are working on gaining approval for their
obesity candidates include
Orexigen Therapeutics, Inc.
(
OREX
) and
Vivus Inc.
(
VVUS
). The US Food and Drug Administration is expected to decide on
Vivus' obesity candidate Qnexa shortly (target date: July 17).